{"id":"digoxin-antibodies-fab-fragments","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypokalemia"},{"rate":null,"effect":"Allergic reactions"},{"rate":null,"effect":"Serum sickness"},{"rate":null,"effect":"Worsening heart failure (from loss of digoxin inotropic effect)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"These monoclonal antibody fragments (Fab) are derived from sheep immunized against digoxin and act as a sequestering agent by binding digoxin with high affinity and specificity. The antibody-digoxin complex is then eliminated renally, rapidly reducing serum digoxin levels and reversing digoxin toxicity. This mechanism allows for rapid reversal of digoxin overdose or toxicity without removing the therapeutic drug already bound to cardiac Na+/K+-ATPase.","oneSentence":"Digoxin-specific antibody fragments bind to and neutralize circulating digoxin, preventing its toxic cardiac effects.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:35:17.975Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Digoxin toxicity or overdose"},{"name":"Life-threatening digoxin toxicity with arrhythmias or hyperkalemia"}]},"trialDetails":[{"nctId":"NCT03810417","phase":"PHASE4","title":"Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2019-07-22","conditions":"Acute Kidney Injury","enrollment":267},{"nctId":"NCT03008616","phase":"PHASE2, PHASE3","title":"Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia","status":"TERMINATED","sponsor":"AMAG Pharmaceuticals, Inc.","startDate":"2017-04-12","conditions":"Severe Preeclampsia","enrollment":59},{"nctId":"NCT01328600","phase":"","title":"Marinobufagenin as a Target for DIGIBIND in Preeclampsia","status":"COMPLETED","sponsor":"National Institute on Aging (NIA)","startDate":"2006-08-16","conditions":"Preeclampsia","enrollment":144},{"nctId":"NCT00158743","phase":"PHASE2","title":"Efficacy Study of Digibind for Treatment of Severe Preeclampsia","status":"COMPLETED","sponsor":"BTG International Inc.","startDate":"2004-02","conditions":"Pre-eclampsia","enrollment":51},{"nctId":"NCT00550576","phase":"PHASE2","title":"Antibodies to Digoxin for Bipolar Disorder","status":"COMPLETED","sponsor":"Rambam Health Care Campus","startDate":"2007-10","conditions":"Bipolar Disorder","enrollment":18},{"nctId":"NCT00852787","phase":"PHASE4","title":"Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease","status":"UNKNOWN","sponsor":"National Institute on Aging (NIA)","startDate":"2009-04","conditions":"Hypertension, Hemodialysis","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Digoxin Antibodies Fab Fragments","genericName":"Digoxin Antibodies Fab Fragments","companyName":"University of Maryland, Baltimore","companyId":"university-of-maryland-baltimore","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Digoxin-specific antibody fragments bind to and neutralize circulating digoxin, preventing its toxic cardiac effects. Used for Digoxin toxicity or overdose, Life-threatening digoxin toxicity with arrhythmias or hyperkalemia.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}